Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

Phase 1

Completed

• Conditions: Patients With Borderline Resectable Pancreatic Cancer
• Interventions: Drug: FIRINOX

• Registration Number: NCT02148549
• Lead Sponsor: Wakayama Medical University

Brief Summary

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

Detailed Description

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Status Verified: 2015-07
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Pathologically proven invasive pancreatic ductal carcinoma

• Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

  1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
  2. Patients indicated distal pancreatectomy with en bloc celiac axis resection

• PS (ECOG) 0-1

• ≧20 years old and < 75 years old

• First line treatment

• The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL

• Written informed consent to participate in this study

Exclusion Criteria

• Severe drug hypersensitivity
• Multiple primary cancers within 5 years
• Severe infection
• With grade2 or more severe peripheral neuropathy
• With intestinal paralysys, ileus
• Interstitial pneumonia or pulmonary
• With uncontrollable pleural effusion or ascites
• Receiving atazanavir sulfate
• With uncontrollable diabetes
• With uncontrollable heart failure, angina, hypertension, arrhythmia
• With severe psychological symptoms
• With watery diarrhea
• Pregnant or lactating women, or women with known or suspected pregnancy
• Inappropriate patients for entry on this study in the judgment of the investigator
• With UGT1A1*28 and/or UGT1A1*6 polymorphisms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optimal chemotherapy courses	FIRINOX	Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients

Primary Outcome Measures

Name	Time	Method
Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Up to 30 weeks.	Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Secondary Outcome Measures

Name	Time	Method
The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Up to 2 years.
The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Up to 24 weeks.
The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.	Up to 30 weeks.

Trial Locations

Locations (9)

Nagoya University; 🇯🇵 Nagoya, Aichi, Japan

Osaka Medical Center for Cancer and CVD; 🇯🇵 Osaka, Japan

Osaka City University; 🇯🇵 Osaka, Japan

Nara Prefectual Medical University; 🇯🇵 Kashihara, Nara, Japan

Kobe University; 🇯🇵 Kobe, Hyogo, Japan

Kansai Medical University; 🇯🇵 Hirakata, Osaka, Japan

Osaka University; 🇯🇵 Suita, Osaka, Japan

Hiroshima University; 🇯🇵 Hiroshima, Japan

Wakayama Medical University; 🇯🇵 Wakayama, Japan